SyntheMed's REPEL-CV gets Russian go-ahead
This article was originally published in Clinica
Executive Summary
The Ministry of Health of the Russian Federation has approved REPEL-CV, SyntheMed's bioresorbable adhesion barrier film, for all patients undergoing open heart surgery. The device is designed to be placed over the surface of the heart after surgery, to reduce the formation of scars, and hence prevent the heart becoming attached to the sternum or other tissues. It will be marketed in Russia by Cardiomedics, a distributor of cardiac surgery products. REPEL-CV received US FDA premarket approval in March for paediatric cardiac surgery patients (see Clinica No 1336, p 27). Iselin, New Jersey-based SyntheMed has also CE marked the film for sale in Europe for all cardiac surgery patients.